UC Davis Health is among the first sites in the nation to offer a clinical trial evaluating a novel device designed to improve blood flow for cardiovascular patients undergoing high-risk, complex coronary artery stenting procedures.
The SUPPORT II Pivotal Study is assessing the investigational Supira System, a low-profile percutaneous ventricular assist device (pVAD) that provides temporary hemodynamic support during high-risk percutaneous coronary intervention.
The trial will enroll up to 385 patients across as many as 40 sites in the United States to evaluate the safety and effectiveness of the system. Patients are randomized to the investigational pVAD system or a larger commercially available pVAD system.
"We are excited to participate in this clinical trial and contribute to advancing care for some of our highest-risk cardiovascular patients," said Garrett Wong, clinical professor of cardiovascular medicine and co-principal investigator of the study. "This trial enables us to offer a procedure to patients who would otherwise be considered too high risk."
What is a pVAD system?
Cardiologists use pVADs during stent placement or angioplasty procedures to support blood flow for high-risk patients with severe coronary artery disease or comorbidities.
Additionally, pVADs are used to treat patients suffering from cardiogenic shock, a condition that can occur following a severe heart attack. The condition is linked to a high rate of morbidity as a patient's heart is suddenly too weak to adequately pump blood to vital organs.
The device in this clinical trial is smaller than current devices. The system includes multiple sensors to collect real-time aortic and ventricular pressures and help guide clinical management.
"Achieving high flow rates has traditionally required larger devices, which can present challenges with both vascular access and positioning," said Tai Pham, assistant professor of cardiovascular medicine and co-principal investigator of the study. "This investigational system's low-profile design aims to reduce the risk of vascular complications associated with larger commercial devices while still providing full hemodynamic support during high-risk coronary interventions."
"Clinical trials like this highlight UC Davis Health's ability to perform complex coronary interventions while offering access to cutting-edge therapies not widely available in the region - providing more options for high-risk patients, including those who might otherwise be considered too high risk for intervention."-Gagan D. Singh
A leader in cardiovascular clinical trials
UC Davis Medical Center was one of only four sites nationwide granted early investigational access to the Supira pVAD System and the first hospital in the Western United States to use it.
Over the past decade, the Clinical Cardiovascular Research Unit has led studies and clinical trials across a broad range of cardiology areas, including heart valve disease, congestive heart failure and hypertension.
"Clinical trials like this highlight UC Davis Health's ability to perform complex coronary interventions while offering access to cutting-edge therapies not widely available in the region — providing more options for high-risk patients, including those who might otherwise be considered too high risk for intervention," said Gagan D. Singh, director of the Clinical Cardiovascular Research Unit.
"I am proud of our team, which is among the most skilled and comprehensive in the nation," Singh said. "Our commitment to delivering complete, efficient and high-quality care continues to drive our leadership in the field."
